510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K251088Substantially Equivalent

Otsuka Digital Feedback Device

Otsuka America Pharmaceutical, Inc, Hayward CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K251088 is the FDA 510(k) clearance record for Otsuka Digital Feedback Device, a class II device, cleared for Otsuka America Pharmaceutical, Inc. on under FDA product code OZW (Ingestible Event Marker). FDA's definition for product code OZW reads: "To provide confirmation of an event co-ingested or coincident with the ingestible component of the device. The wearable component of the device incorporates wireless communication to display the event and other information on a general...". FDA records list 3 510(k) clearances for Otsuka America Pharmaceutical, Inc., from to . As of , FDA records show no recalls naming K251088.

Clearance record

Decision date
Received
(82 days to decision)
Product code
OZW Ingestible Event Marker
Regulation
21 CFR 880.6305
Device class
Class II
Review panel
General Hospital
Applicant
Otsuka America Pharmaceutical, Inc. 3956 Pt. Eden Way, Hayward CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OZW

Trailing 12 months

FDA records hold no clearances under product code OZW in the trailing twelve months.

FDA records show no clearances under product code OZW in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code OZW, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260